Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 173 for:    Recruiting, Not yet recruiting, Available Studies | psychiatric disorder OR bipolar OR depression | Brain Stimulation

DBS of the Habenula for Treatment- Resistant Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347487
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

Brief Summary:
The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness and safety of bilateral DBS to habenula for patients with TRD. This study will also use structural and functional MRI to explore the underlying mechanism of Hb's effects on TRD.

Condition or disease Intervention/treatment Phase
Treatment Resistant Major Depression Disorder Procedure: Deep brain stimuation system implantation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive bilateral surgical implantation of DBS system.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep Brain Stimulation of Bilateral Habenula Procedure: Deep brain stimuation system implantation
All subjects will receive bilateral surgical implantation of DBS system.The Medtronic DBS 3389 electrode is utilized in this study. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller.
Other Names:
  • DBS
  • Activa RC System




Primary Outcome Measures :
  1. changes in the Hamilton Depression Scale(HAMD-17) score from baseline to 9 months [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    The score of the scale ranges from 0 to 50.

  2. changes in the Montgomery-Asberg Depression Rating Scale from baseline to 9 months [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    The score of the scale ranges from 0 to 60.


Secondary Outcome Measures :
  1. changes in the brain activity [ Time Frame: Baseline (preoperative),one month, 9 months ]
  2. Side Effects [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
  3. Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    YMRS is an eleven-item multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. The score of the scale ranges from 0 to 60. Higher score means more severity of mania.

  4. Changes in Hamilton Anxiety Scales(HAMA) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    Clinician administered assessment.The score of the scale ranges from 0 to 56.

  5. Global Assessment of Functioning Scale(GAF) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    Clinician administered assessment.The score of the scale Scores range from 100 (extremely high functioning) to 1 (severely impaired).

  6. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    Clinician administered assessment.The Screener contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.

  7. Changes in Beck Depression Inventory [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    Self-rating scale. The score of the scale ranges from 0 to 63. Higher score means more severity of depression.

  8. Chang in Pittsburgh Sleep Quality Index [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21. The high score means poor quality of sleep.

  9. World Health Organization Quality of Life-BREF(WHO-BREF) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. It contains 26 items which is a 5 points scale. The higher score means better quality of life.

  10. the MOS item short from health survey (SF-36) [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The higher score means better quality of life.

  11. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand-alone items. The raw total score ranges from 14 to 70.

  12. Sheehan Disability Scale [ Time Frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months ]
    Self-rating scale. The SDS is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS assesses functional impairment in three major life domains: work, social life/leisure activities, and family life/home responsibilities. The higher scores mean more severity of disability.

  13. Changes in Neuropsychological measures(Scores of CANTAB tasks) [ Time Frame: Baseline (preoperative),3 months, 9 months ]
    Neuropsychological measures contains six tasks which are Stop Signal Task, Spatial Working Memory, Paired Associated Learning, Stocking of Cambridge, Intra Extra dimensional Set Shifting, Reaction time Task



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women(non-pregnant) aged 18-65 years old;
  • DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5) of a current major depressive episode(MDE), either nonpsychotic unipolar major depressive disorder (MDD) or bipolar disorder (BD);
  • Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months) and a minimum of 5 y since the onset of the first depressive episode;
  • For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder)
  • Treatment resistance defined as Failure of at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA+, lithium-addition) for a period of 6-8 weeks. If diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
  • At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT). Or unable to recieve ECT.
  • Symptom Severity: HAMD-17 total ≥21;
  • Stable antidepressant medical regimen for the month preceding surgery;
  • Anticipates a stable psychotropic medication regimen in the next 12 months;
  • Able and willing to give written informed consent;
  • Modified mini-mental state examination (MMSE) score ≥ 27;

Exclusion Criteria:

  • Schizophrenia /history of psychosis unrelated to MDD;
  • Severe personality disorder (assessed by SCID-II);
  • Alcohol or substance abuse/dependence within 6 months, excluding nicotine dependence;
  • Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year;
  • Neurological disease (e.g., Parkinson's disease)
  • Any history of seizure disorder or hemorrhagic stroke;
  • Abnormal brain MRI ;
  • Previous sterosurgery;
  • Any medical contraindication to surgery;
  • Does not have adequate family/friend support as determined by psychological screening and/or interview;
  • Unable to maintain a stable psychotropic medication regimen in the next 12 months;
  • Pregnant or has plans to become pregnant in the next 12 months;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347487


Contacts
Layout table for location contacts
Contact: Chencheng Zhang, MD +086-18217122884 i@cczhang.org

Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital Functional Neurosurgery Recruiting
Shanghai, Shanghai, China, 200025
Contact: Chencheng Zhang, MD    +086-18217122884    i@cczhang.org   
Contact: Yingying Zhang, MSc    +086-17602137369    zhyy019@126.com   
Sponsors and Collaborators
Ruijin Hospital

Publications:

Layout table for additonal information
Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03347487     History of Changes
Other Study ID Numbers: 2018 DBS-Hb MDD
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bomin Sun, Ruijin Hospital:
Bilateral Habenula
Treatment Resistant Major Depressive Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders